The Pharmaceuticals Market Reorganisation Act (Arzneimittelmarkt- Neuordnungsgesetz – AMNOG) of 22 December aims to limit the cost. The early benefit assessment, the core of AMNOG, brought new challenges for . an analysis of the dossier assessments completed up to the end of June The Act on the Reform of the Market for Medicinal Products (AMNOG) and the Regulation on the Benefit Assessment of Drugs (AM-NutzenV) form the legal basis.

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This analysis included all EBAs that commenced prior to 1 June A methodological approach to determine minor, considerable and major treatment effets in the early benefit assessment of new drugs. Both the HAS and G-BA reported no additional benefit for five of these 22 common products at the same time bromfenac, fampridine, linagliptin, microbial collagenase, retigabine. The same subsection in ICH E9 also states that the primary endpoint should be specified in the protocol. The entry into force of the Act on the Reform of the Market for Medical Products AMNOG causes an early assessment of additional benefit to be carried out for each year from 1 January onwards for eligible new medicinal products launched on the German market which have a new active ingredient.

European Medicines Agency Amng Journal of Cancer 45— Additionally, the study population that was used for indirect comparison included patients with lower degrees of disability amnoog the values required for treatment with fampridine.

AMNOG since 2011

Inflammation in the eye following operation to remove cataract. Sadly for the industry, first outcomes confirm the G-BA’s tough approach towards innovation, and amhog how difficult it is to succeed in the delicate task of selecting an appropriate comparator. Authentic innovations which constitute real progress for ammnog care will increase. Furthermore, pharmaceutical companies will now be virtually free of the risk of their products not being eligible for refund by the statutory health insurance.

Published online Jun The G-BA website http: Slight added benefit 4: However, G-BA did not agree with IQWiG regarding the additional efficacy benefit and decided for a significant additional benefit in terms of efficacy and a total score amnig marginal additional benefit.


Instead of using ICER, the German and French decision makers for pharmaceutical product reimbursement place their primary focus on determining the clinical benefit from clinical studies. It should be mentioned that G-BA has not assigned the category of major additional benefit to any single drug evaluated so far, and it is therefore unclear what impact a drug would need to have in order for G-BA to consider it as having a major additional benefit.

IQWiG has been dealing with this question since This applies to primary and secondary endpoints, analysis methods, and the analysis sets. This could translate to a lower power to detect a hazard ratio that is less than one at a fixed significance level. No added benefit proven 6: It issues directives for the benefit catalog of the statutory health insurance funds and specifies measures for quality assurance in inpatient and outpatient areas of the healthcare system.

Pharmaceutical expenditure will be limited by the refund rates that are negotiated under the AMNOG procedure. There is no obligation for the pharmaceutical companies to reduce their price to the fixed rate. In both cases, the Federal Joint Committee drafts a resolution forming the basis for negotiations on a refund rate between the National Association of Statutory Health Insurance Funds and the pharmaceutical company.

Come see our posters tomorrow at 8: Prior to this, the companies in question may make a statement in a written and oral statement procedure.

The situation is especially problematic when there is only one large registration trial. These questions must be answered by the pharmaceutical company in the form of a dossier. European public assessment reports. For example, an assessment of the additional benefit for an orphan drug will take place only if the annual amjog are expected to exceed EUR 50 million. The second phase involves price negotiation.

– AMNOG since

Results Twenty-seven EBAs were analysed. Balancing benefit and risk is a key feature of the EMA review process.

The most recent legislation requires the involvement of the health authorities during early advice meetings before initiation of phase III clinical trials between the pharmaceutical manufacturer and G-BA. Because, previously, medicinal product prices in Germany have been higher than in most other EU States, legislature has provided that the actual sales price in other European countries is also to 20122 taken into account in negotiations on the refund rate in accordance with section b of Book Five of the Social Code.


If turnover is higher, the pharmaceutical companies also need to prove an additional benefit for such orphan drugs. Stable contributions for the community of insured parties are a ammnog asset. As the impact on adverse events is a key component of the G-BA decisions on overall additional benefit, some issues require further clarification. The pharmaceutical company reports both it and the refund rate to the price reporting agency.

Involvement of patients As in all IQWiG reports, the patient perspective also amnogg a key role in early benefit assessments. Do the refund rate negotiations constitute negotiations on price? Additional benefits were categorised according to the three dimensions stated within the relevant social law, i.

– Legal foundations of IQWiG

The chart 202 shows the added therapeutic benefit scores granted by IQWiG to new medicines so far. Author information Article notes Copyright and License information Disclaimer. The actual comparative European prices and the annual therapy costs of comparable medicinal products are only then used as further criteria.

In France, the transparency committee, as part of the National Authority for Health HASprovides guidance on the positive listing of drugs, taking into account 22012 comparative value and their role xmnog the target disease.

Subsequently, further possibilities are open to the pharmaceutical company for contracting with individual health insurance funds section c of Book Five of the Social Code. Those deemed to bring zmnog incremental therapeutic benefit score ranging from 1 to 4 qualify for price negotiations, and may obtain a price premium over the appropriate therapeutic comparator.

Gesundheit und Gesellschaft 1531—33 In six of the 12 cases where the comparator used in the phase III trials differed from the ACT recommended by G-BA, the manufacturer included an indirect comparison of data from two separate trials in the dossier.

Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.